Ignite Creation Date:
2024-05-06 @ 10:19 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03226054
Status:
TERMINATED
Last Update Posted:
2018-12-04
First Post:
2017-07-19
Brief Title:
Determining Risk Factors for Successful PPI Weaning
Sponsor:
Mount Carmel Health System
Organization:
Mount Carmel Health System
Study Overview
Official Title:
Determining Risk Factors for Successful PPI Weaning
Status:
TERMINATED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not logistically feasible to continue enrolling patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastroesophageal Reflux Disease GERD can happen when stomach acid flows backward into your esophagus tube from the mouth to the stomach causing symptoms such as heartburn Proton pump inhibitors called PPIs are a type of medication that reduce acid in the stomach and are used to reduce the discomfort from GERD Treatment for GERD with PPIs is recommended to last up to eight weeks however many people take them for longer periods Some people are placed on PPIs particularly in the hospital to prevent ulcers and inflammation of the stomach but they do not need to be on the medication long term Previous research studies have shown that there are some risks with taking PPIs for a long time These risks include the inability of your body to absorb some vitamins and minerals certain infections such as pneumonia or the digestive tract infection called C diff and possibly bone fractures Therefore it is desirable to stop taking a PPI when possible
The purpose of this study is to use a standard approach to help patients stop taking PPIs by adopting lifestyle habits known to reduce the symptoms of GERD while they slowly reduce their PPI dose All medications used for this study are approved by the US Food and Drug Administration FDA You are being asked to take part in this study because you have been taking a PPI for longer than the recommended time and have either a diagnosis of GERD gastritis or an unclear indication for being on a PPI About 100 patients from the Mount Carmel St Anns Family Medicine practice will participate in this research
The purpose of this study is to use a standard approach to help patients stop taking PPIs by adopting lifestyle habits known to reduce the symptoms of GERD while they slowly reduce their PPI dose All medications used for this study are approved by the US Food and Drug Administration FDA You are being asked to take part in this study because you have been taking a PPI for longer than the recommended time and have either a diagnosis of GERD gastritis or an unclear indication for being on a PPI About 100 patients from the Mount Carmel St Anns Family Medicine practice will participate in this research
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None